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NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Drug Resistant Epilepsy Clinical Trial

Official title:
A Pilot, Single Blind, Randomized Crossover Study to Evaluate the Safety and Efficacy of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Clinical Trial Summary

To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy

Clinical Trial Description

This is a pilot, single blind, randomized crossover design, and single center. DRE patients with a determined epileptogenic foci will be enrolled. After completing the informed consent, patients will enter the 28-day screening period for baseline observation. Patients who had at least 3 seizures during the screening period will be eligible to participate the clinical trial. Eligible patients will be randomized into two groups to receive Sham treatment or FUS treatment on day 1. After FUS/Sham treatment, patients will be under home monitor to record the seizure by daily diary card for 1 month. After 1 month (Day 30±7), patients will be crossed over to the other treatment. Another one month observation will be necessary. In this trial, patients will totally receive 2 treatments: one FUS treatment, and one Sham treatment. Sixty (±7) days after day 1, patients will have a follow-up visit and overall evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04999046
Study type Interventional
Source NaviFUS Corporation
Contact Ruby Lin, Master
Phone (886)2-25860560
Email ruby.lin@navifus.com
Status Recruiting
Phase N/A
Start date September 1, 2021
Completion date June 2024
View Details
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